AT/H/0661/001/DC, final SmPC SUMMARY OF PRODUCT CHARACTERISTICS [Invented name] 4 mg/g + 25 mg/g ointment 1 AT/H/0661/001/DC, final SmPC 1. NAME OF THE MEDICINAL PRODUCT [Invented name] 4 mg/g + 25 mg/g ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g ointment contains 4 mg nonylic acid vanillylamide (nonivamide) and 25 mg β-butoxyethylester of nicotinic acid (nicoboxil). Excipient(s) with known effect 1 g ointment contains 2 mg sorbic acid. Fragrance with with α-Isomethyl ionone, α-Amylcinnamaldehyde, α-Amylcinnamyl alcohol, Anisyl alcohol, Evernia furfuracea extract (Treemoss extract), Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Citral, Citronellol, Coumarin, Oakmoss extract, Eugenol, Farnesol, Geraniol, α-Hexylcinnamaldehyde, Hydroxycitronellal, Isoeugenol, Butylphenyl methylpropional (Lilial), Limonene, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral), Methyl heptane carbonate, Cinnamaldehyde, Cinnamyl alcohol . (see section 4.4) Benzyl alcohol: less than 0.002 mg/100g (see section 4.4) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment Almost white or slightly yellowish, opaque, smooth homogeneous ointment with odour of citronella oil. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications To stimulate blood flow in the skin for treating muscle and joint complaints. For treatment of acute low back pain with no signs of neuropathic origin. To stimulate blood flow in the skin before taking a capillary blood sample, e.g. from the earlobe or the digital pulp. 4.2 Posology and method of administration Posology Treatment should start with a very small quantity and on a very small skin area to test individual reaction. Response to [Invented name] 4 mg/g + 25 mg/g ointment varies and some people only need a very small amount to generate a warming feeling while others might experience very little or no warming effect. [Invented name] 4 mg/g + 25 mg/g ointment 2 AT/H/0661/001/DC, final SmPC Starting dose should be not more than ½ cm ointment (about the size of a pea) for an area the size of the palm. Even small amounts produce a noticeable effect of warming, which occurs a few minutes after application and develops its maximum effect during 20-30 minutes. At the following applications the dose can be intensified, corresponding to the individual tolerance. Maximum recommended dose per application should be 1 cm of ointment for an area the size of 1 palm. [Invented name] 4 mg/g + 25 mg/g ointment should be used when needed, up to 2-3 times per day. The maximum daily dose should not exceed 3 applications. Paediatric population The safety and efficacy of [Invented name] 4 mg/g + 25 mg/g ointment has not been established in children and adolescents under 18 years. Method of administration For cutaneous use The ointment should be spread lightly over the painful area, using the enclosed applicator and should be spread with the hand until only a slight gloss can be seen on the skin. After using [Invented name] 4 mg/g + 25 mg/g ointment hands should be washed thoroughly with soap and water. To stimulate blood flow in the skin before taking a capillary blood sample 1-2 cm of ointment per treatment To prepare for a blood sample apply the ointment to the intended site of injection (earlobe or digital pulp) approximately 10 minutes beforehand and massage into the skin. Before taking the blood sample wipe off any residual ointment and disinfect the area of skin. Wearing disposable gloves is recommended. Care should be taken to avoid any ointment being transferred to other areas of skin or other persons. 4.3 Contraindications – Hypersensitivity to nonylic vanillylamide or β-butoxyethylester of nicotinic acid or to any of the excipients listed in section 6.1; – very sensitive skin; – open wounds; – dermatitis; – diseased skin. 4.4 Special warnings and precautions for use Due to local skin hyperaemia induced [Invented name] 4 mg/g + 25 mg/g ointment redness, feeling of warmth, itching and burning at the application site are to be expected. These symptoms may be particularly marked if the amount [Invented name] 4 mg/g + 25 mg/g ointment applied is excessive or [Invented name] 4 mg/g + 25 mg/g ointment is intensively rubbed on the skin area. Excessive use or rubbing of [Invented name] 4 mg/g + 25 mg/g ointment may cause blisters of the skin. Patients have to be informed, that – hands should be thoroughly washed with soap and water immediately after application of [Invented name] 4 mg/g + 25 mg/g ointment, in order to avoid a transferring to unintended skin areas or to other people; – [Invented name] 4 mg/g + 25 mg/g ointment should be applied under no circumstances to the face, eyes or mouth, as this may result in transient face swelling, facial pain, conjunctival irritation, ocular hyperaemia, eye burning, visual disturbance, oral discomfort and stomatitis; [Invented name] 4 mg/g + 25 mg/g ointment 3 AT/H/0661/001/DC, final SmPC – [Invented name] 4 mg/g + 25 mg/g ointment should not be used on sensitive skin areas should such as neck, lower abdomen or inside of the thighs; – the skin of people with bright hairs or sensitive people generally can react stronger and therefore the thermal stimulus can be reached even with very low doses of [Invented name] 4 mg/g + 25 mg/g ointment; – before or after applying [Invented name] 4 mg/g + 25 mg/g ointment patients should not take a hot bath or shower, as even hours after application of [Invented name] 4 mg/g + 25 mg/g ointment redness of skin and an intensive feeling of warmth can be induced by sweating or application of warming effects. [Invented name] 4 mg/g + 25 mg/g ointment contains sorbic acid. Sorbic acid may cause local skin reactions (e.g. contact dermatitis). Allergens This medicine contains fragrance with α-Isomethyl ionone, α-Amylcinnamaldehyde, α-Amylcinnamyl alcohol, Anisyl alcohol, Evernia furfuracea extract (Treemoss extract), Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Citral, Citronellol, Coumarin, Oakmoss extract, Eugenol, Farnesol, Geraniol, α-Hexylcinnamaldehyde, Hydroxycitronellal, Isoeugenol, Butylphenyl methylpropional (Lilial), Limonene, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral), Methyl heptane carbonate, Cinnamaldehyde, Cinnamyl alcohol The allergens mentioned above may cause allergic reactions. Benzyl alcohol (included in the list of allergens) Benzyl alcohol may cause allergic reactions and mild local irritation 4.5 Interaction with other medicinal products and other forms of interaction Interactions with other medicinal products, either locally or systemically administered, are not known. 4.6 Fertility, pregnancy and lactation Pregnancy and breast-feeding No data are available for [Invented name] 4 mg/g + 25 mg/g ointment regarding administration during pregnancy and lactation. Use of [Invented name] 4 mg/g + 25 mg/g ointment is therefore not recommended during pregnancy and lactation. Fertility No studies on the effect on human fertility have been conducted. 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. 4.8 Undesirable effects The following side effects are based on the post-marketing experience and dataset of 202 clinical trial patients treated with 0.4 % nonivamide and 2.5 % nicoboxil ointment. Frequency is given according the following convention: Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: 1/1,000 to < 1/100 [Invented name] 4 mg/g + 25 mg/g ointment 4 AT/H/0661/001/DC, final SmPC Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000 Not known: cannot be estimated from the available data Immune system disorders Not known: anaphylactic reactions, hypersensitivity reactions Nervous system disorders Common: skin burning sensation Not known: paraesthesia Respiratory, thoracic and mediastinal disorders Not known: cough, dyspnoea Skin and subcutaneous tissue disorders Common: erythema, pruritus Uncommon: rash Not known: application site pustules, localised skin reactions, blister, swelling face, urticaria General disorders and administration site conditions Common: feeling hot Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose Symptoms After excessive use of [Invented name] 4 mg/g + 25 mg/g ointment the hyperaemic effects may be aggravated and the severity of the described side effects may increase. Excessive use may especially result in the occurrence of blisters in the affected skin area where [Invented name] 4 mg/g + 25 mg/g ointment was administered. Since nicotinic acid esters show a good percutaneous absorption the overdose of [Invented name] 4 mg/g + 25 mg/g ointment may result in systemic reactions - e.g. redness of the upper part of the body, increase of body temperature, hot flushes, painful hyperaemia and a decrease in blood pressure. Therapy If too much [Invented name] 4 mg/g + 25 mg/g ointment has been applied, the effect can be reduced by dabbing the skin with a swab soaked in oil (at best olive oil) or enriched in cream. Symptomatic therapy should be applied. Measures in accidental oral administration: charcoal, liquid paraffin, analgesics, if necessary. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents ATC code: M02AB [Invented name] 4 mg/g + 25 mg/g ointment 5 AT/H/0661/001/DC, final SmPC [Invented name] 4 mg/g + 25 mg/g ointment contains two vasodilating active substances, which produce an intensive thermal stimulus on the skin for many hours.